Website LanceSoft Inc
LanceSoft Inc
Company : LanceSoft Inc
Job Description:
Job Title: QA Engineer
Job Duration: 12-18+ month
Est. Pay Range: $35- $38/hr (USD)
Work Type Onsite
Description:
Summary:
Client is the premier laboratory partner for a better world. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Client enables customers to gain the insights they seek so they can do what they do best: improve the world around us.
Our Quality Engineer role is dedicated to ensuring the highest quality experiences for our patients and customers. This position provides engineering guidance, expertise, and services to ensure process, data, and product quality.
Quality Engineers lead and drive process and product improvements and provide specialized quality-related services to R&D, Quality Assurance, Manufacturing Engineering, Production, Procurement, and Marketing. They develop, implement, and evaluate tools and equipment for quality assurance and product/process improvement.
We are currently seeking a Quality Engineer to support our Cedar Creek, Texas, operations.
Additional responsibilities will include:
- Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms.
- Support 3rd party audit of site through audit prep and participating in the front/back room.
- Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.
- Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.
- Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback.
- Act as an SME in quality assurance and scientific matters as applicable.
- Develop and drive key strategic quality assurance initiatives throughout the organization.
- Contributes to the development of new projects/programs/processes.
- Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc.
- Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions.
Job Posting Qualifications
- Bachelor’s or Master’s Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.
- Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred.
- 4+ years of experience in a similar position within the Life science industry.
- Familiarity with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is required.
- Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations.
- An effective communicator at all levels, both internally and externally.
- Team player with the ability to make independent decisions within the framework and guidelines of the organization.
- Relocation assistance is available.